How to Navigate the Updated FDA Cosmetic Product Registration and Listing and MoCRA in 2025
As the beauty industry evolves, so do the regulatory requirements that guide it. The FDA recently updated its guidance on cosmetic product facility registration and product listing to align with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). These updates are crucial for businesses operating in the U.S. to ensure compliance while maintaining product safety and consumer trust. Here’s what you need to know.
What’s New in FDA’s Cosmetic Guidelines?
The updated guidance outlines mandatory steps for cosmetic facility registration and product listing under Section 607 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift replaces the FDA’s previous voluntary cosmetic registration program, which ended in March 2023.
Key Updates:
- Facility Registration Requirements: All facilities that manufacture or process cosmetic products for U.S. distribution must register with the FDA. Registration must be renewed every two years, and updates must be submitted within 60 days of any changes.
- Product Listing Requirements: Each cosmetic product must be listed with the FDA, including details such as the facility registration number, product ingredients, and categories. Listings must be updated annually, even if the product is discontinued.
- Compliance Timeline: The FDA has extended the enforcement deadline to July 1, 2024, allowing businesses more time to adjust to the new system.
- Public Disclosure: While some information will be made public, sensitive details such as product listing numbers and facility registration numbers will remain confidential.
Topics Covered in New FAQs:
- Responsibilities of the U.S. Agent: Clarifies the roles and obligations of U.S. agents under MoCRA.
- FEI Numbers for Multi-Building Facilities: Provides guidance on managing Facility Establishment Identifier (FEI) numbers for facilities with multiple manufacturing or processing buildings.
- Product Listing for Free Samples: Details the requirements for registering promotional cosmetic products.
Simplified Path for Small Businesses
One of the most significant highlights of the guidance is the small business exemption. This exemption applies to businesses with annual gross sales under $1,000,000 (adjusted for inflation) over the previous three years.
Who Qualifies for the Exemption?
- Small businesses are exempt from registration and listing requirements unless they manufacture products that:
- Regularly contact mucous membranes (e.g., eye makeup).
- Are injected or intended for internal use.
- Have long-lasting effects (over 24 hours) without consumer removal.
For small businesses meeting these criteria, the FDA does not require exemption documentation or provide certificates. This ensures a streamlined process while maintaining essential safety checks for high-risk products.
Submission Made Easy
To simplify compliance, the FDA has introduced Cosmetics Direct, an electronic portal for submitting registrations and listings. Businesses can also use paper forms or submit through the Electronic Submissions Gateway (ESG).
What You’ll Need for Registration:
- Facility and owner details.
- Product brand names and categories.
- Ingredient lists, including fragrances and colors.
Annual updates and biennial renewals are mandatory to maintain compliance.
Highlights of the Guidance:
- Who must register facilities and list products.
- What information needs to be included in submissions.
- How and when required information should be submitted.
- Exemptions to registration and listing requirements.
Comment Period Open Until January 13, 2025
Stakeholders are encouraged to submit feedback on the new draft FAQs before they are finalized. Comments can be submitted electronically or in writing, as specified in the Federal Register Notice.
How Chicscience Labs Can Help You with FDA Cosmetic Product Registration and MoCRA Compliance
At Chicscience Labs, we specialize in helping cosmetic businesses navigate the complexities of FDA compliance. From facility registration to product listing and understanding MoCRA requirements, our team of experts is here to guide you every step of the way. We offer tailored services, including:
- Comprehensive compliance reviews for facility and product registrations.
- Assistance with submitting accurate product listings, including ingredient breakdowns and labeling.
- Expert guidance for small businesses to determine exemptions and streamline compliance.
Let us help you ensure compliance while focusing on what you do best—delivering exceptional cosmetic products.
Why This Matters
These updated guidelines reflect the FDA’s commitment to modernizing cosmetic regulations while balancing the needs of small businesses. By standardizing safety measures and ensuring transparency, the beauty industry is set to build greater consumer confidence and maintain high safety standards.
What’s Next?
For more details on the submission process and FAQs, visit the FDA’s Cosmetic Product Registration and Listing page. By staying informed and prepared, your business can seamlessly adapt to these changes and continue delivering products that consumers trust and love.
